PathChat DX granted “Breakthrough Device” Designation by the FDA
Pathology AI co-pilot “PathChat DX” has been granted Breakthrough Device designation by the U.S. Food and Drugs Administration (FDA), underscoring its potential to significantly improve medical diagnostics.
PathChat, developed by Modella AI, is an advanced generative AI system designed to enhance pathologists’ workflow by providing intelligent insights and decision support for complex cases. It processes clinical data, delivers diagnostic insights, and assists with challenging case analysis, including answering intricate medical questions and identifying key patterns in pathology images.
Such analysis is possible due to its custom multimodal large language model and pathology foundation model which has been trained on a massive database of human histopathology slides. This allows PathChat to recognise and interpret both visual and non-visual medical data.
The impressive capabilities of this technology were demonstrated in 2024 by research published in Nature, PathChat was provided with clinical data and evaluated on its ability to answer a range of diagnostic questions. The study found that when PathChat was provided with both pathology data and relevant clinical context (such as patient age and sex), it achieved an impressive accuracy of up to 89.5% on multiple-choice diagnostic questions.
Pathologists often face incredibly demanding and intricate challenges in their workload, where rapid and correct identification of tissue or fluid samples is critical for appropriate treatment decisions, and mistakes can have catastrophic consequences. Tools such as PathChat are designed to support them with this difficult burden, improving patient care through increased speed and accuracy of sample analysis and subsequent treatment plans.
Every medical device must go through long and rigorous assessments to gain approval by the FDA for use in the U.S. However, in certain cases, when a new product has the potential to significantly improve the current standard of healthcare, it will join the FDA’s Breakthrough Device Program. This is a voluntary program reserved for medical technology that has the potential to provide “more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions”.
The advantages of joining the program include expedited, priority assessments and increased opportunities for the device’s development team to collaborate with the FDA throughout the process. This is to ensure that the product’s potential benefits can reach patients and healthcare staff faster than they would have been if they were to go through the standard route, while still partaking in detailed and complete safety assessments.
In January 2025, PathChat DX—a “clinical grade” extension of PathChat developed in Mahmood Lab led by Modella AI Co-Founder Faisal Mahmood—was granted Breakthrough Device status, highlighting its potential as a possible gamechanger within medical diagnostics.
Other medical devices that have been accepted into the Breakthrough Device cohort include the Silverlon® Wound Contact and Burn Contact Dressing, a flexible dressing plated with silver to help fight infections, and the OsteoBoost Belt, which uses vibrations to slow the loss of bone density and strength in post-menopausal women.
In a press release, Professor, Surgical Pathologist and Scientific Advisor Dr Alexander Lazar noted:
“With the rising demands and challenges in pathology, including growing workloads and burnout, tools like PathChat DX offer an opportunity to help pathologists improve both their efficiency and resilience in our complex field.”
In response to the designation of PathChat DX as a Breakthrough Device, Dr. Jill Stefanelli, Modella AI’s CEO and President stated:
“This milestone brings us closer to our mission of using generative and agentic AI to accelerate diagnostic workflows.”